BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2082127 · Received April 27, 2011

    Report

    Report Number
    9610816-2011-00201
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    March 31, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A MONITOR FELL AND WAS DAMAGED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION REVEALED THAT A CLINICIAN INSERTED A CONNECTED NIBP CUFF UNDER THE MOUNT RELEASE BUTTON AND LEFT THE MONITOR IN AUTOMATIC NIBP MEASUREMENT MODE WHEN HE LEFT THE ROOM. AFTER A PERIOD OF TIME, THE NIBP CUFF INFLATED AND RELEASED THE MONITOR FROM THE MOUNT AND LIFTED THE MONITOR FROM THE MOUNT. THERE WAS NO MALFUNCTION OF THE MONITOR OR MOUNTING HARDWARE. BOTH THE MOUNTING HARDWARE OPERATION AND THE AUTOMATIC NIBP FUNCTION ARE ADEQUATELY DESCRIBED IN THE DEVICE LABELING (IFU). NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A MONITOR FELL AND WAS DAMAGED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1